VALIDATION OF METHODS FOR THE ASSAY OF FLURBIPROFEN AND FLURBIPROFEN SODIUM, RELATED-COMPOUNDS AND VOLATILE IMPURITIES IN RAW-MATERIALS AND TABLETS

被引：8

作者：

BEAULIEU, N

CYR, TD

LOVERING, EG

机构：

[1] Bureau of Drug Research Health Protection Branch Health and Welfare Tunney's Pasture, Ottawa, ON

来源：

DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY | 1991年 / 17卷 / 13期

关键词：

D O I：

10.3109/03639049109074396

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

A high performance liquid chromatographic method has been developed for the assay of flurbiprofen, or flurbiprofen sodium and related compounds in drug raw materials and tablets. A phenyl column with a mobile phase of acetonitrile: 1.0% acetic acid (60:40) provide for the resolution of twenty-one related compounds from the drug. Minimum detectable levels of the related compounds are 0.01% and minimum quantifiable levels are 0.1% or less. Total impurity levels in seven raw materials ranged from 0.0 to 0.6%. One impurity, 2-(4-biphenylyl) propionic acid, is present in most samples at about 0.3%. A gas chromatographic method was developed for organic volatile impurities.

引用

页码：1843 / 1855

页数：13